Device Classification Name |
recorder, magnetic tape, medical
|
510(k) Number |
K230184 |
Device Name |
Holter ECG and ABP System |
Applicant |
Edan Instruments, Inc. |
#15 Jinhui Road,Jinsha Community, |
Kengzi Sub-District Pingshan District |
Shenzhen,
CN
518122
|
|
Applicant Contact |
Lavender Wang |
Correspondent |
Edan Instruments, Inc. |
#15 Jinhui Road,Jinsha Community, |
Kengzi Sub-District Pingshan District |
Shenzhen,
CN
518122
|
|
Correspondent Contact |
Lavender Wang |
Regulation Number | 870.2800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/23/2023 |
Decision Date | 09/25/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|